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Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Indolent Plasma Cell Myeloma; Plasma Cell Myeloma; Smoldering Plasma Cell Myeloma

Intervention: Anakinra (Biological); Dexamethasone (Drug); Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Placebo (Other)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
John Lust, Principal Investigator, Affiliation: Mayo Clinic

Summary

This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.

Clinical Details

Official title: A Phase I/II Double Blind Randomized Trial of Lenalidomide/ Dexamethasone/ Anakinra vs. Lenalidomide/Dexamethasone/Placebo in Patients With Early Stage Multiple Myeloma and a High Plasma Cell Growth Rate

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Incidence of adverse events, graded according to NCI CTCAE version 4.0

Incidence of toxicity graded according to Common Toxicity Criteria

MTD of lenalidomide, dexamethasone, and anakinra defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)

Response profile (Phase I)

Time to disease progression (TTP) (Phase II)

Secondary outcome:

Overall response rate (ORR) (Phase II)

Survival time (Phase II)

Detailed description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of anakinra that can be combined with lenalidomide and dexamethasone. (Phase I) II. To compare the time to progression of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). (Phase II) SECONDARY OBJECTIVES: I. To compare the response rate of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). II. To compare the toxicity of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). III. To compare the overall survival of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). OUTLINE: This is a phase I, dose-escalation study of anakinra followed by a phase II study. PHASE I: Patients receive lenalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra subcutaneously (SC) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive lenalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive lenalidomide and dexamethasone as in Arm A. Patients also receive placebo SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Serum creatinine =< 1. 5 x upper limit of normal (ULN)

- Absolute neutrophil count (ANC) >= 1700/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin >= 8. 0 g/dL

- Diagnosis of multiple myeloma according to International Myeloma Working Group

criteria and one of the following:

- Smoldering multiple myeloma (SMM)

- Indolent multiple myeloma (IMM)

- Newly diagnosed multiple myeloma (MM)

- Note: patients with lytic disease and anemia are eligible

- High risk disease defined by all of the following:

- >= 10% bone marrow plasma cells AND

- Serum monoclonal immunoglobulin (M-protein) >= 3 g/dL OR urine M-protein >= 500

mg/24 hours (hr) AND

- Monotypic plasma cell S-phase >= 1%

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

- Provide signed informed consent

- Negative (serum or urine) pregnancy test done =< 7 days prior to registration, for

women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative

- Willing to return to enrolling institution for follow-up (during the active

monitoring phase of the study) Exclusion Criteria:

- Prior treatment with any other agent that may affect M-protein =< 30 days prior to

registration

- Acute/chronic infections, open wounds, or any active infection requiring intravenous

antibiotic therapy =< 12 weeks prior to registration

- Other active malignancy (=< 3 years) prior to registration; exceptions: non-melanotic

skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate

contraception

- New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF)

symptoms

- Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered

investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States; Not yet recruiting
Clinical Trials Referral Office, Phone: 855-776-0015
John A. Lust, Principal Investigator
Additional Information

Starting date: July 2015
Last updated: July 6, 2015

Page last updated: August 23, 2015

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